Clinical Trial: When Research Goes Wrong
Monday, November 28, 2011
Three patients died in an unapproved medical trial conducted between 2003 and 2004.
Now, the executives of Snythes Inc., a medical-device company, are awaiting sentencing this week after pleading guilty to a misdemeanor as "responsible corporate officers," according to Business Week.
The Synthes officials allegedly bypassed FDA protocol to have surgeons test bone cement in people with spine fractures. The product was not approved for that use, and three people died in the operating room in 2003 and 2004.
The patients who died suffered a severe drop in blood pressure following the injections. The surgeons involved could not rule out the bone cement as a factor in the deaths, but it also wasn't definitively responsible.
Synthes pleaded guilty to corporate health care fraud charges and agreed to pay $23 million in fines.
Prosecutors in the case want one-year prison terms for "human experimentation." According to prosecutors, the executives not only tested the bone cement on humans, but failed to report the deaths and lied to FDA investigators.
Each defendant has lost his job and been fined $100,000.
Although this is an extreme example of a recent case, clinical research fraud allegations are common. Medical and clinical researchers, whether in an academic community or in a practice setting, may be accused of research misconduct, altering data, falsifying results, misrepresenting data, or other forms of research misconduct. It is imperative that the researcher obtain experienced legal counsel to represent him or her in such matters. An accusation, even if later proven to be unfounded, may unfairly tarnish the personal and professional reputation of the researcher, cause him or her to lose grants, bonuses and promotions and may even lead to termination of employment.
There are many additional more serious and far-reaching consequences that may also result. In addition to possible immediate consequences already mentioned above, the following are other consequences that may result from such complaints being made against a researcher:
- Suspensions from employment.
- Termination of employment.
- Removal from the department or school.
- Placement into an administrative position or transfer to another campus or another job site.
- Removal from positions such as Department Chair, Vice Chair, or Lead Investigator positions.
- The requirement to retract a published article or chapter in a book (or certain potions of it). Please note: if this occurs, there are a number of websites and organizations which monitor such matters which will pick up this information and will republish it with the implication that the researcher was required to do this because of falsification of data or lack of integrity. This alone will permanently tarnish the reputation of the researcher.
- A requirement that the institution refund the grant money for the grant.
- Loss of tenure of the researcher.
- Loss of the authority of the researcher to participate in any other government contracting activities (often referred to as "debarment" or exclusion"). This will also cause the researcher's name and identifying information to be placed on websites and list maintained by the General Services Administration (GSA) and other federal agencies. This also prohibits a person who is "debarred" form being an owner, operator, employee or contractor of anyone else (or any other business entity) that is a government contractor. This also causes the researcher to be placed on the List of Excluded Individuals and Entities (LEIE) maintained by the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), which means that the researcher will also be excluded form the Medicare Program and any state Medicaid programs.
- Reporting to the National Practitioner Data Bank (NPDB) for any individual who is a licensed health professional such as a medical doctor or registered nurse.
- Loss of any future grants by the individual.
- Publication on the research fraud website maintained by the National Institutes of Health (NIH) Office of Research Integrity (ORI).
- Administrative discipline by the institution overseeing the investigation or research.
- Civil or administrative complaints being bought for the recovery of salaries, bonuses, expenses, fines or costs of investigation.
- Criminal prosecution for fraud, theft or other applicable crimes.
In many cases, the researcher accused of such misconduct may actually be the victim of one or more unscrupulous individuals who make the complaint for his or her own ulterior motives. These may include disgruntled former employees or researchers who have lost their jobs or who have been denied renewal of contracts. They may include those who have racial, sexual, religious or other prejudices. They may include those who seek monetary rewards under laws and statutes that promote such reporting (including "whistle blower" and qui tam statutes). They may include persons who perceive that they have been wronged or slighted by the researcher involved. They may include those who make such complaints "preemptively" because they fear that their jobs, contracts or tenure will be jeopardized in the future.
In many cases such complaints will be based on the honest motives of the person making the complaint who may have just misunderstood or mis-perceived facts and circumstances. Regardless, the best approach will usually be to take the high road, avoid personal attacks (in most cases) against the complainer, and just defend against the allegations being made with accurate facts, documents and information.
Obtaining an experienced attorney at the earliest stages of an investigation can help the researcher to avoid many pitfalls and mistakes that can harm or even give up defense opportunities the researcher may have. At the very least, legal guidance can assist in presenting the researcher's side of the case in an effective and organized manner that does not compromise a legal defense. Going out and retaining an aggressive trial attorney who is unfamiliar with such matters can often be counter-productive and actually lessen the chances of a researcher coming out of an investigation unscathed.
A "scorched earth" or "bull in a china shop" approach is often employed by some litigation attorneys not experienced in handling such cases. This is often perceived by the academic or physician members of the committee appointed to investigate the matter as being an impediment to reliable communication and academic honesty, as well as an obstructionist attempt to hide the truth. In some rare cases this may be necessary, but in most it will be counter-productive and will hurt the chances of the researcher obtaining a favorable result.
Although federal statutes and regulations provide the authority and general guidance for conducting such proceedings, including a requirement that any such accusations be reported to the NIH, the actual procedures that must be followed will be set forth in state administrative rules or the internal policies and procedures of the academic institution concerned. The state's Administrative Procedure Act (APA) will also govern such matters. A working knowledge of how such procedures work and of administrative law is crucial. Although criminal charges may come out of such investigations, a knowledgeable, experienced health law attorney may be able to obtain a resolution without anyone even considering such action.
The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians and clinicians who are the subject of such complaints. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers, investigators and "whistle blowers" who report such matters including those who become the victim or reprisals and retaliation by the person against whom the report is made.
Don't wait. Obtain the advice and counsel of experienced attorneys who are familiar with such matters and can assist you before it is too late.
For more information visit www.TheHealthLawFirm.com.
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